Product code LGP— Hematology

FDA has cleared 5 devices under product code LGP between 1981 and 1986, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19861 clearance
• 19851 clearance
• 19841 clearance
• 19812 clearances

• American Dade2 clearances
• Warner-Lambert Co.1 clearance
• Kabivitrum, Inc.1 clearance
• Instrumentation Laboratory CO1 clearance

• K864213 — IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAYInstrumentation Laboratory CO·1986-11-25
• K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAYWarner-Lambert Co.·1985-05-08
• K833890 — COATEST ANTIPLASMINKabivitrum, Inc.·1984-01-30
• K802840 — ALPHA-ANTIPLASM ASSAYAmerican Dade·1981-02-17
• K803110 — PROTEOLYTIC ENZYME CONTROLAmerican Dade·1981-02-17